Report on Compulsory Licensing Provisions in the National Patent Legislation of 15 Middle-Income Countries:
A Content Analysis and Recommendations
A Report of the Global Economic Governance Initiative of the Boston University Global Development Policy Center
Published by the South Centre and the Global Economic Governance Initiative of Boston University Global Development Policy Center
This study examines compulsory licensing laws in 15 middle-income countries often excluded from voluntary licenses & finds significant untapped policy space to advance access to affordable medicines. It highlights best practices & makes key recommendations to improve patent laws for the use of this important TRIPS flexibility.
Are countries maximizing the policy space they have to grant compulsory licenses to improve access to medicines?
Webinar
Date & Time: Thursday, 13 November 2025, 13h-14h30 (Geneva) / 7h-8h30 (Boston) / 23h-00h30 (Melbourne)
Join the Launch of a Report onCompulsory Licensing Provisions in the National Patent Legislation of 15 Middle-Income Countries, published by the South Centre and the Global Economic Governance Initiative of Boston University Global Development Policy Center.
South Centre Statement to the Intergovernmental Working Group (IGWG) on the WHO Pandemic Agreement
3 November 2025
This statement was delivered at the opening of the Intergovernmental Working Group (IGWG) on the WHO Pandemic Agreement, third session, on 3 November 2025. The South Centre underscored that the first draft Bureau text helps to kick off text-based negotiations, but it does not meet the requirements for implementation of Article 12 of the Pandemic Agreement.
Co-organized by the National Commission on International Trade & Health Studies (NCITHS), Thailand together with the International Trade & Health Programme (ITH), South Centre & other partners
On September 24, 2025, two agreements were announced with generic drug manufacturers in India for the supply of generic lenacapavir at $40 (instead of the original $28,218) per patient per year. However, these generics can only be supplied to the countries included in Gilead’s voluntary license, excluding too many from accessing this price.
The negotiations on the Pathogen Access and Benefit Sharing System under the WHO Pandemic Agreement: State of Play as of September 2025
By Viviana Munoz Tellez, German Velasquez
The World Health Organization (WHO) Member States adopted a Pandemic Agreement in May 2025 but deferred negotiations on the critical Pathogen Access and Benefit Sharing System (PABS). Despite the tight timeline, the Intergovernmental Working Group (IGWG) has made minimal progress as of September 2025, with no draft text produced and formal negotiations yet to begin. The PABS system is essential for pandemic equity, balancing rapid pathogen sharing with equitable access to vaccines and treatments. But with the current approach to the IGWG process, without formal negotiations underway, Member States risk failing to finalize the PABS Annex by the March 2026 deadline.
New Amendments to the International Health Regulations: Strengthening Access to Health Products in Emergencies and Pandemics
By Viviana Munoz Tellez
The International Health Regulations amendments entered into force on September 19, 2025 across most World Health Organization (WHO) Member States. These updates don’t give WHO any new powers but help countries work better together to advance fair and timely access to health products such as vaccines, treatments and diagnostics needed to respond to health emergencies. The real challenge now is implementation and building the necessary capabilities to make these improvements function.
The Importance of Balanced Intellectual Property Systems for Patients’ Access to Medicines: An Analysis
By Archana Jatkar and Nicolás Tascón
Access to safe, effective, cost-effective, and quality-assured medicines is fundamental from a patients’ perspective. The International Generic and Biosimilar Medicines Association (IGBA) recently released a reporthighlighting the critical balance between innovation, competition, and timely access to medicines. This article delves into the key findings of IGBA’s report, their implications on patient access to medicines and national healthcare budgets, and the IGBA’s recommendations for improving the global pharmaceutical landscape.
Access to medical products and reproductive rights
Side Event to the 59th Session of the Human Rights Council
23 June 2025
12:00 to 13:00
Room XXVII, Palais de Nations, Geneva, Switzerland
The pursuit of health equity, encompassing fair and just opportunities for all to achieve their full health potential, remains a paramount global challenge. The right to health is a fundamental part of our human rights and of our understanding of a life in dignity. This event will explore the indivisible links between equitable access to medical products, the advancement of sexual and reproductive health and rights (SRHR), and the strengthening of international cooperation as pillars for upholding this fundamental right for everyone, everywhere. The interconnectedness of these themes is central; they are not disparate issues but integral components of a holistic approach necessary to realise comprehensive health equity.
The side event is anticipated to significantly enhance participants’ understanding of the complex, intersecting challenges and opportunities in upholding health equity, particularly through improved access to medical products and the full realization of SRHR. The discussions aim to identify potential policy pathways, innovative approaches, and actionable strategies for key stakeholders to address existing inequities. Furthermore, a crucial outcome will be a reinforced commitment to multilateralism and collaborative action as essential tools for tackling global health challenges and advancing the right to health, with the dialogue contributing valuable insights to ongoing policy debates in relevant international fora, especially concerning the implementation of recent global agreements and agendas, while also strengthening networks and partnerships dedicated to health equity and human rights.
Scope of Compulsory License and Government Use of Patented Medicines
To meet public health needs governments can use compulsory licenses and government use as a tool for procurement and import of patented medicines. These mechanisms are provided for in most laws worldwide. The WTO TRIPS Agreement, as reaffirmed by the Doha Declaration on TRIPS and Public Health, recognises the right of WTO members to grant compulsory licenses and their freedom to determine the grounds upon which such licenses may be granted.
This table provides information of instances of their use.
Application de l’Exception Bolar: Différentes approches dans le droit de l’UE
Par Dmytro Doubinsky
Ce Document de recherche aborde le problème toujours plus aigu de l’accès aux médicaments essentiels, en se concentrant sur le rôle des droits de propriété intellectuelle, en particulier les droits de brevet, qui restreignent l’accès en permettant des monopoles sur le marché pharmaceutique qui maintiennent les prix des médicaments à un niveau élevé. Le document explore l’exception Bolar, un mécanisme juridique conçu pour permettre aux fabricants de médicaments génériques de demander l’approbation réglementaire avant l’expiration d’un brevet, empêchant ainsi l’extension de facto des monopoles de brevets. L’étude examine la transformation de l’exception Bolar d’un cas juridique spécifique en un instrument important en matière de droit de la propriété intellectuelle, de droit commercial et de droit pharmaceutique. Elle analyse les principaux cadres juridiques internationaux et les directives européennes relatifs à l’exception Bolar et met en évidence les interprétations divergentes de l’exception dans les jurisprudences allemande et polonaise. Grâce à cette analyse comparative, le document encourage une mise en œuvre plus large des exceptions Bolar afin d’améliorer l’accès à des médicaments abordables et de réduire les coûts des soins de santé.
Submission by the South Centre to the Office of the United Nations High Commissioner for Human Rights on Inputs for the comprehensive report on ensuring access to medicines, vaccines and other health products (HRC resolution 50/13)
January 2025
The South Centre has provided input for the OHCHR report on new developments and challenges in ensuring access to medicines, vaccines and other health products.
